(Updated December 2007)
Description of Health Care System
In the UK, healthcare is provided by the National Health Service (NHS) and is free at the point of service. The NHS is funded through general taxation. For more details on the NHS, see UNITED KINGDOM. NHS Scotland is responsible for providing healthcare to Scotland.
In Scotland, the provision of healthcare is devolved to regional Health Boards. Although funded centrally from the UK Department of Health, NHS Scotland manages the allocation of funding to the 9 Health Boards of Scotland. The Health Boards are then responsible for the provision of health care to their areas. Each Health Board has an Area Drugs and Therapeutic Committee (AD&TC) which advise on the use of medicines for their area. However, in order to ensure that medicines are equally available to all people in Scotland, and it is not dependent where they live, the Scottish Medicines Consortium (SMC) was established to assess all new medicines at launch as to whether they are cost effective for use in Scotland. If a product is approved by SMC, it is automatically added to the AD&TC formulary which allows it to be prescribed on the NHS Scotland. If a product is not recommended by SMC, it will not be included on the AD&TC formulary and access will be limited.
Reimbursement and Pricing Approval Process
The remit of the SMC is to provide advice to NHS Boards and their AD&TCs across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products (licensed from January 2002 when SMC began). The advice will be made available as soon as practical after launch of the product.
SMC remit excludes vaccines, branded generics, non Prescription Only Medicines (POMs), blood products and diagnostic drugs. The review of devices containing a medicine is confined to those licensed as a medicine by the MHRA/EMEA.
The SMC process requires pharmaceutical companies to complete a New Product Assessment form. The timescales involved require the submission to be made ahead of product launch. Companies are advised to contact the SMC before making a submission to inform the SMC of the likely timings. The submission form, and guidance notes on how to complete it, is provided on the SMC website. There is also a checklist for the economic part of the form which must be completed and submitted for all applications.
Companies are required to complete the New Product Assessment Form which has the following sections:
- SECTION 1 – Registration Details and Alternative Treatments
- SECTION 2 – Summary
- SECTION 3 – Efficacy
- SECTION 4 – Comparative Safety
- SECTION 5 – Clinical Effectiveness
- SECTION 6 – Pharmacoeconomic Evaluation
- SECTION 7 – Resource Implications
There is also an abbreviated submissions form which is used in the case of new formulations or strengths where there is clinical equivalence or superiority and the cost is the same or less per treatment.
All submissions are reviewed by the New Drug Committee (NDC) who provides a draft detailed advice. Companies are able to review this draft advice, and provide comments, before it is submitted to the SMC for consideration. SMC then make the final decision as to whether the product will be recommended, not recommended or recommended with restrictions for use in Scotland. Companies and the Health Boards are informed of the final advice before it is published on the website.
It is possible to make a re-submission to SMC if new data becomes available which impacts the cost effectiveness of the product.
The SMC meets on the 1st Tuesday of every month and the New Drug Committee (NDC) meets the last Tuesday of each month. Full details of the timetables for submissions are also provided on the website.
Role of SMC and NICE
Health Technology Assessment for England and Wales is separate from Scotland and is the responsibility of the National Institute of Clinical Excellence (NICE). SMC and NICE assess new products independently, however, both agencies assess a new product on the basis of clinical and cost effectiveness. An economic evaluation of any new product in relation to current standard clinical practice is essential for approval.
However, SMC differs from NICE in that:
- SMC assesses new products or indications at the time of launch
- SMC does not perform their own economic assessment of the product but uses the Company submitted data to assess cost effectiveness
NHS: QIS NHS Quality Improvement Scotland
SMC: Scottish Medicines Consortium
Reimbursement Organizations/HTA Organizations
NHS Scotland is responsible for providing healthcare to Scotland.
Scottish Medicines Consortium (SMC) was established to assess all new medicines at launch as to whether they are cost effective for use in Scotland. All the information regarding SMC and contact details are provided at their website www.scottishmedicines.org.uk
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